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| Model Number 1DLMC02 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240)
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| Event Date 09/25/2008 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2007 whereby a gore dualmesh® biomaterial device was implanted.The complaint alleges that on (b)(6) 2008, the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, pain, adhesions, and mesh removal.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Corrected conclusion code.Concomitant medical products : added medical record summary.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6)2017 , including prior abdominal procedures, were not provided.Operative records dated (b)(6)2017 indicate the patient underwent ¿ventral and umbilical hernia repair with mesh.¿ postoperative diagnosis states: ¿ventral incisional hernia, umbilical hernia.¿ the (b)(6)2017 operative report states: ¿forty-six-year-old female who recently underwent a laparoscopic cholecystectomy.Unfortunately, the patient is somewhat obese and her supra umbilical trocar incision has resulted in a ventral hernia without evidence of incarceration.I elected to take the patient to surgery for an operative repair.We elected to pursue an open approach in that she is trying to obtain clearance for laparoscopic placement of a gastric band and any additional intraperitoneal manipulation i thought could potentially complicate this upcoming surgery.¿ ¿the patient had a surprisingly large incisional hernia in a supraumbilical position.She was also noted to have an umbilical hernia with properitoneal fat.¿ the(b)(6)2007 records state: ¿the old scar at the supraumbilical position was noted and a transverse incision was made after infiltrating 0.5% marcaine into the subcutaneous tissues.This was deepened with cautery.A hernia sac was identified and dissected free at the level of the fascia.Just inferior to this there was an umbilical hernia noted as well.I elected to take the skin of the umbilicus off the hernia sac.There was a thin rim of fascia between the two hernias, so i elected to divide this making one single hernia defect.The hernia sac was then divided with cautery at the level of fascia and sent off the field as a specimen.Omentum was present.No evidence of bowel.Intraperitoneal placement of dual mesh was then performed with the rough side facing the peritoneum.Multiple 0 ethibond stitches were used to tack the mesh to the undersurface of the fascia circumferentially.The air was irrigated with antibiotic containing solution and suctioned dry.Once the fascia had been placed in a retrofascial position, the fascia itself was then closed over the top of this with a running 0 prolene stitch.The skin of the umbilicus was then tacked down to the fascia with a pair of 3-0 vicryl stitches.The deep dermis was closed with 3-0 vicryl and then skin clips were applied followed by a pressure dressing and an abdominal binder.¿ the records confirm a gore dualmesh® biomaterial (1dlmc02/04854977) was used during the procedure.Surgical pathology report signed 11/13/2007 states final pathologic diagnosis ¿hernia sac, herniorrhaphy.Changes consistent with ventral hernia.¿ gross description states: ¿the specimen consists of an irregular portion of fatty fibroconnective tissue measuring 4.0 x 3.0 x 1.5 cm.On section, the fibroconnective tissue is saccular in nature and incarcerates some of the fatty tissue.No worrisome areas of induration are identified.¿ the mircroscopic description states: ¿sections reveal an attenuated single layer of cuboidal to flattened mesothelial cells with an underlying connective tissue stroma.Other areas demonstrate mild vascular congestion.Dysplastic atypia and malignancy are not seen.¿ operative report dated(b)(6)2008 indicates the patient underwent ¿removal of unincorporated previous mesh with repair of the recurrent incisional hernia with bard composite mesh system.¿ postoperative diagnosis states: ¿recurrent incisional hernia.¿ the (b)(6)2008 operative report states: ¿ms.Quinby is a 47-year-old female who underwent a previous ventral hernia repair.She has developed a recurrence with new bulging and pain in the area consistent with recurrence.¿ ¿incision was made using a previous transverse scar, carried down through subcutaneous tissue.The mesh was encountered which essentially had not incorporated.The side of the dual mesh which was supposed to incorporate in the entire lower half had broken free from the fascia with a recurrent hernia.The mesh was completely excised and the fascial edges circumferentially freshened up completely circumferentially with freeing up of any omental adhesions back in the abdominal cavity.Once the fascial edges were freed, circumferentially anteriorly and posteriorly a large bard composite mesh was soaked in antibiotic irrigation and positioned in correct orientation.The prolene portion of the mesh was then sewn to the edges of the fascia circumferentially with 2-0 ethibond to give a repair without tension.The fascial edges all appeared to be in good shape.This was inspected upon completion and all appeared well.The wound was irrigated and inspected again and all appeared well.Further marcaine was infiltrated.The subcutaneous tissue was closed with 3-0 vicryl and skin was closed with running subcuticular 4-0 vicryl.Lndermil skin glue was used to seal the skin.Specimen removed for pathology was unincorporated mesh." operative report dated 10/11/2008 indicates the patient underwent ¿i and d of infected hernia repair wound.¿ the postoperative diagnosis states: ¿infected hernia repair wound.¿ the (b)(6)2008 operative report states: ¿this is a woman who underwent repair of recurrent ventral hernia with mesh per dr.Rohrer several weeks ago.She presented to the emergency room early this morning with erythematous incision and surrounding cellulitis.She is brought to surgery now for incision and drainage of same.¿ ¿her incision was reopened down to a seroma cavity which was evacuated after sending fluid for culture.The mesh was exposed and only partially incorporated suggesting potential mesh involvement.Rather than leaving the packing directly on the mesh and risking contamination it was felt best to irrigate and closed over a 10 blake drain pending cultures in an effort to preserve the mesh if possible.A 10 blake drain was placed into the wound cavity, brought out through a stab incision below and to the left of the incision and sutured to the skin with nylon suture.The wound was loosely reapproximated with nylon mattress sutures and sterile dressing applied." a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2007: (b)(6), md.Operative report.Anesthesiologist: (b)(6), md.Anesthesia method: general.Circulator: (b)(6), rn.First scrub: (b)(6) surgical tech.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia, umbilical hernia.Operation performed: ventral and umbilical hernia repair with mesh.Indications: forty-six-year-old female who recently underwent a laparoscopic cholecystectomy.Unfortunately, the patient is somewhat obese and her supraumbilical trocar incision has resulted in a ventral hernia without evidence of incarceration.I elected to take the patient to surgery for an operative repair.We elected to pursue an open approach in that she is trying to obtain clearance for laparoscopic placement of a gastric band and any additional intraperitoneal manipulation i thought could potentially complicate this upcoming surgery.Findings: the patient had a surprisingly large incisional hernia in a supraumbilical position.She was also noted to have an umbilical hernia with preperitoneal fat.Complications: none.Estimated blood loss: less than 10 ml.Crystalloid infused: please refer to the anesthesia check sheet.Technique: ¿i spoke with the patient describing the nature of the procedure, as well as the associated risks, benefits, options, alternatives to care, and potential complications, and consent was obtained.The patient was taken to the operating room, placed on the table in the supine position, attached to cardiovascular monitoring devices.General anesthetic was administered.Compression device stockings were placed and perioperative antibiotics were given.Her abdomen was then prepped and draped in the usual manner.The old scar at the supraumbilical position was noted and a transverse incision was made after infiltrating 0.5% marcaine into the subcutaneous tissues.This was deepened with cautery.A hernia sac was identified and dissected free at the level of the fascia.Just inferior to this there was an umbilical hernia noted as well.I elected to take the skin of the umbilicus off the hernia sac.There was a thin rim of fascia between the two hernias, so i elected to divide this making one single hernia defect.The hernia sac was then divided with cautery at the level of fascia and sent off the field as a specimen.Omentum was present.No evidence of bowel.Intraperitoneal placement of dual mesh was then performed with the rough side facing the peritoneum.Multiple 0 ethibond stitches were used to tack the mesh to the undersurface of the fascia circumferentially.The air was irrigated with antibiotic containing solution and auctioned dry.Once the fascia had been placed in a retrofascial position, the fascia itself was then closed over the top of this with a running 0 prolene stitch.The skin of the umbilicus was then tacked down to the fascia with a pair of 3-0 vicryl stitches.The deep dermis was closed with 3-0 vicryl and then skin clips were applied followed by a pressure dressing and an abdominal binder.The patient appears to have tolerated the procedure nicely and is currently being extubated to be taken to the recovery room in satisfactory condition.¿ product identification records for the alleged ¿dual mesh¿ were not provided.[missing records: per operative report dated (b)(6) 2008, patient had ¿repair of recurrent ventral hernia with mesh per dr.Rohrer several weeks ago¿; these records were not provided.] (b)(6) 2008: (b)(6), md.Operative report.Anesthesiologist: (b)(6), md.Circulator: (b)(6), rn.First scrub: (b)(6) c.S.T.Preoperative diagnosis: infected hernia repair wound.Postoperative diagnosis: infected hernia repair wound.Operative procedure: i and d [incision and drainage] of infected hernia repair wound.Operative indications: this is a woman who underwent repair of recurrent ventral hernia with mesh per dr.Rohrer several weeks ago.She presented to the emergency room early this morning with erythematous incision and surrounding cellulitis.She is brought to surgery now for incision and drainage of same.Operative procedure description: ¿the patient was brought to the operating room, placed on the or table in the supine position, where she underwent induction of general anesthesia without difficulty and was prepped and draped sterilely.Her incision was reopened down to a seroma cavity which was evacuated after sending fluid for culture.The mesh was exposed and only partially incorporated suggesting potential mesh involvement.Rather than leaving the packing directly on the mesh and risking contamination it was felt best to irrigate and closed over a 10 blake drain pending cultures in an effort to preserve the mesh it possible.A 10 blake drain was placed into the wound cavity, brought out through a stab incision below and to the left of the incision and sutured to the skin with nylon suture.The wound was loosely reapproximated with nylon mattress sutures and sterile dressing applied.The patient tolerated the procedure well with minimal blood loss and was transferred to the recovery room, awake and in stable condition at the completion of the procedure.¿ [dquinby-3gfsa-kba-24-25] [missing records: a culture report detailing analysis of the specimens collected during the 10/11/08 procedure was not provided.] records between (b)(6) 2008 and (b)(6) 2017 were not provided.(b)(6) 2017: [missing records: records for ct abdomen/pelvis showing ¿supraumbilical hernia with fat¿ were not provided.] (b)(6) 2017: (b)(6), md.Emergency room report.Abdominal pain 3-4 days duration.Abdominal distention.Recently hospitalized, had upper gastrointestinal, told she has multiple adhesions.Impression: intestinal obstruction, abdominal pain.Admitted.(b)(6) 2017: (b)(6), md.Radiology ¿ ct abdomen/pelvis.History: abdominal distention and pain.Possible obstruction.Impression: there is mildly prominent loop of small bowel at the bleeding edge of the contrast column in the right abdomen.This may be transient.Otherwise there is no dilated bowel.There is a mild amount of stool in the colon.Stable midline anterior abdominal wall hernia.(b)(6) 2017: (b)(6), md.Consultation report.Upper abdominal pain, nausea.She tells me it has been present for about six months but worse recently.Similar symptoms 05/31/17, was admitted, upper gastrointestinal series done to investigate complaint of epigastric pain and bloating.Contrast study showed some appropriate delay at the lap band but no ulceration.Did no appeared displaced.Recalls being told she may have multiple intra-abdominal adhesions from her various surgeries.She thinks adhesions could be the source of her current problems.Primary care physician has told her ¿lap band should come out.¿ lost 120 lbs after initial placement in (b)(6) 2009 but she thinks it is no longer working and is still morbidly obese.History of gastroesophageal reflux.According to history and physical her brief one-day hospitalization beginning (b)(6) 2017 was shortened by her leaving ama [against medical advice] before cardiac test could be done.Ct scan of abdomen/pelvis on (b)(6) 2017 showing no acute problems, supraumbilical hernia with fat.Impression/plan: abdominal pain, nausea, vomiting, history of erosive esophagitis, morbid obesity, multiple medical problems.Plan esophagogastroduodenoscopy later today.If esophagogastroduodenoscopy is normal may consider surgical evaluation regarding adhesions or other pathology not seen on recent ct scan.(b)(6) 2017: (b)(6), md.Office notes.Lap-band problems.Bariatric failure, may wish to have her lap-band removed/or converted to a different bariatric procedure to address her obesity and diabetes as well as bariatric failure and gastroparesis.Wishes to have her lab band deflated.Impression/plan: morbid obesity, gastroparesis.Discussed accessing and deflating the port.She agreed.This was accomplished using sterile technique, but unfortunately, the port could not be accessed as it appears to have pulled away from the abdominal wall and flipped upside down.Requesting possible lap-band removal and revisional surgery as described.Referred to bariatric surgeon.(b)(6) 2017: (b)(6), md.Office notes.Presents to bariatric surgery clinic for evaluation.Significant bloating symptoms, problems with her port, has tenderness with palpation and manipulation, appears to be flipped.Gastric emptying study has proven gastroparesis.Upper gi in (b)(6) 2017 showed normal band positioning without reflux or gastric prolapse or esophageal dysmotility.History of cesarean section x 2, cholecystectomy, hysterectomy with bladder suspension, hernia repair x 3 (incisional hernia repaired open, recurrence treated with open mesh repair, mesh infection that then resolved), appendectomy.Weight 227.6 lbs.Exam: abdomen: port palpable in left lateral abdomen, but is tender to palpation and manipulation without skin changes suggestive of infection.Medications: amoxicillin [antibiotic].Impression/plan: abnormal bloating, nausea, chronic vomiting.Discussed options about revisional surgery.I am not sure that her symptoms are completely attributed to her band.Her gastroparesis appears to be the main cause of her bloating and nausea symptoms.Upper gastrointestinal study did not show band complication.Her bloating and abdominal discomfort secondary to bloating is what she is primarily concerned with.She does not want to pursue conversion to a sleeve or bypass at this time.Recommend we attempt to empty the band.(b)(6) 2018: [missing records: records for ct abdomen/pelvis showed ¿midline anterior abdominal wall hernia¿ were not provided.] (b)(6) 2019: benefis hospitals.(b)(6), md.Office notes.Severe abdominal pain.Impression/plan: (b)(6) 2018 ct abdomen/pelvis showed 1mm calculus at uvj mild right hydroureteronephrosis mild hepatis steatosis, gastric lap band is in place, midline anterior abdominal wall hernia, status post herniorrhaphy unchanged.Gastroparesis; dr.Mortensen tried to deflate it on (b)(6) 2017 but was unsuccessful.Type 2 diabetes mellitus with long term current use of insulin.Ordered ct abdomen/pelvis.(b)(6) 2019: (b)(6), md.Radiology ¿ ct abdomen/pelvis.History: abdominal pain.Bulge in abdomen for 2 years.History of hepatic steatosis with hepatosplenomegaly and anterior abdominal wall hernia.Findings: midline anterior abdominal wall hernia repair changes are again noted.Outward bulging of the hernia mesh is again noted.Fat-containing hernias are again demonstrated along the lateral margin of the repair mesh bilaterally.There is a 4.1 cm hernia on the left, compared to 2.7 cm previously.There is a 3.8 cm hernia on the right compared to 2.5 cm previously.(b)(6) 2019: (b)(6), md.Radiology ¿ ct abdomen/pelvis.Indication: abdomen distention, nausea, vomiting, diarrhea.Left lateral abdomen pain.Multiple surgeries.Findings: a midline anterior abdominal wall hernia contains mesh and fat and is unchanged.Fat herniates lateral to the mesh bilaterally.(b)(6) 2019: (b)(6), rn.Addendum.Subject: mesh.Per request of dr.Engan, mesh is identified as 1) gore dual mesh and 2) bard venrtolux.(b)(6) 2019: (b)(6), md.Office notes.Discussion regarding lap band as well as her hernias.Exam: protuberant fullness present near umbilicus.Impression/plan: incisional hernia.Discussed removal of lap band is a good idea.Ct scan showing 2 small fat-containing recurrent incisional hernias near her midline and there is a diastases of 9cm at this level.The hernia, may approach with a rtar [robotic transverse abdominis release procedure].(b)(6) 2019: (b)(6), md.Office notes.Abdominal pain.In emergency room yesterday for distention, nausea, vomiting, diarrhea.Ct scan showing no evidence of obstruction and a stable abdominal wall repair following her hernias.In 2007 i operated on her for [sic] hernias.Since then 2 other surgeons have operated apparently there is a new mesh and she apparently had a mesh infection and is now involved two lawsuits against meshes that apparently has been recalled.Had a lap band put in that this is no longer functional.The midportion of her abdomen is ¿hard¿ she describes difficulty in bending over.Unintentional thirty-pound weight gain over the last 6 months.Surgical referral made.Plan: recommended removal of the port and lap band.I want to research a little bit about her subsequent abdominal wall surgeries and mesh.(b)(6) 2019: (b)(6), md.Office notes.Abdomen continues to have significant negative impact on her health and overall well-being.This will be her 6th attempt at repair of her abdominal wall hernias.We also agreed to remove the lap band.Unintentional weight loss.Weight 242 lbs.Impression/plan: incisional hernia.Robotic removal of lap band coupled with a robotic tar [transverse abdominis release procedure].Agreed to participate in the quality collaborative through the americas hernia society.There is no mention of gore device removal in the records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes h6: updated device codes h6: additional patient codes: 1670: use of device problem h6: updated conclusion codes h6: additional conclusion codes: 4315: cause not established the investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes (1994, 1695) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: ¿ the known medical records span november 9, 2007 through august 1, 2019, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.¿ records from october 11, 2008 through june 13, 2017 were not provided.Patient information: medical history: ¿ type ii diabetes ¿ morbid obesity - (b))6) 2017: 222 lbs.; bmi 38.1 - (b)(6) 2017: 227.6 lbs.; bmi 39.1 - (b)(6) 2019: 241.6 lbs.; bmi 41.5 - (b)(6) 2019: 242.8 lbs.; bmi 41.7 - (b)(6) 2019: 242 lbs.; bmi 41.5 ¿ intestinal obstruction ¿ gastroparesis ¿ bariatric failure prior surgical procedures: [dates unknown for the following surgeries] ¿ cesarean section x2 ¿ appendectomy ¿ bilateral tubal ligation ¿ total abdominal hysterectomy ¿ laparoscopic cholecystectomy ¿ 4/09: laparoscopic placement of gastric band implant preoperative complaints: ¿ 11/9/07: ¿recently underwent a laparoscopic cholecystectomy.Unfortunately, the patient is somewhat obese and her supra umbilical trocar incision has resulted in a ventral hernia without evidence of incarceration.¿ implant procedure: ¿ventral and umbilical hernia repair with mesh.¿ implant: gore® dualmesh® biomaterial (04854977/1dlmc02) 8cm x 12cm.Implant date: november 9, 2007 [hospitalization dates unknown] ¿ description of hernia being treated: ¿the patient had a surprisingly large incisional hernia in a supraumbilical position.She was also noted to have an umbilical hernia with properitoneal fat.¿ ¿a hernia sac was identified and dissected free at the level of the fascia.Just inferior to this there was an umbilical hernia noted as well.I elected to take the skin of the umbilicus off the hernia sac.There was a thin rim of fascia between the two hernias, so i elected to divide this making one single hernia defect.The hernia sac was then divided with cautery at the level of fascia and sent off the field as a specimen.Omentum was present.No evidence of bowel.¿ ¿ implant size and fixation: ¿intraperitoneal placement of dual mesh was then performed with the rough side facing the peritoneum.Multiple 0 ethibond stitches were used to tack the mesh to the undersurface of the fascia circumferentially.The air was irrigated with antibiotic containing solution and suctioned dry.Once the fascia had been placed in a retrofascial position, the fascia itself was then closed over the top of this with a running 0 prolene stitch.¿ ¿ no post-operative records were provided.Explant preoperative complaints: ¿ 9/25/08: ¿she has developed a recurrence with new bulging and pain in the area consistent with recurrence.¿ explant procedure: ¿removal of unincorporated previous mesh with repair of the recurrent incisional hernia with bard composite mesh system.¿ explant date: (b)(6) 2008 [hospitalization dates unknown] ¿ ¿incision was made using a previous transverse scar, carried down through subcutaneous tissue.The mesh was encountered which essentially had not incorporated.The side of the dual mesh which was supposed to incorporate in the entire lower half had broken free from the fascia with a recurrent hernia.The mesh was completely excised and the fascial edges circumferentially freshened up completely circumferentially with freeing up of any omental adhesions back in the abdominal cavity.Once the fascial edges were freed, circumferentially anteriorly and posteriorly a large bard composite mesh was soaked in antibiotic irrigation and positioned in correct orientation.The prolene portion of the mesh was then sewn to the edges of the fascia circumferentially with 2-0 ethibond to give a repair without tension.¿ ¿ records confirm a non-gore device was implanted during the (b)(6) 2008 procedure.Relevant medical information: ¿ (b)(6) 2008: ¿i and d [incision and drainage] of infected hernia repair wound.¿ - ¿presented to the emergency room early this morning with erythematous incision and surrounding cellulitis.She is brought to surgery now for incision and drainage of same.¿ ¿her incision was reopened down to a seroma cavity which was evacuated after sending fluid for culture.The mesh was exposed and only partially incorporated suggesting potential mesh involvement.Rather than leaving the packing directly on the mesh and risking contamination it was felt best to irrigate and closed over a 10 blake drain pending cultures in an effort to preserve the mesh if possible.A 10 blake drain was placed into the wound cavity, brought out through a stab incision below and to the left of the incision and sutured to the skin with nylon suture.The wound was loosely reapproximated with nylon mattress sutures and sterile dressing applied.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.Use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the mesh.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device codes.H6: additional patient codes: 1670: use of device problem.H6: updated conclusion codes.H6: additional conclusion codes: 4315: cause not established.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes (1994, 1695) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span november 9, 2007 through august 1, 2019, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Records from october 11, 2008 through june 13, 2017 were not provided.Patient information: medical history: type ii diabetes: morbid obesity, on (b)(6) 2017: 222 lbs.; bmi 38.1, on (b)(6) 2017: 227.6 lbs.; bmi 39.1, on (b)(6) 2019: 241.6 lbs.; bmi 41.5, on (b)(6) 2019: 242.8 lbs.; bmi 41.7, on (b)(6) 2019: 242 lbs.; bmi 41.5, intestinal obstruction, gastroparesis, bariatric failure.Prior surgical procedures: [dates unknown for the following surgeries].Cesarean section x2, appendectomy, bilateral tubal ligation, total abdominal hysterectomy, laparoscopic cholecystectomy, on (b)(6) : laparoscopic placement of gastric band.Implant preoperative complaints: on (b)(6) 2007: ¿recently underwent a laparoscopic cholecystectomy.Unfortunately, the patient is somewhat obese and her supra umbilical trocar incision has resulted in a ventral hernia without evidence of incarceration.¿ implant procedure: ¿ventral and umbilical hernia repair with mesh.¿ implant: gore® dualmesh® biomaterial (04854977 / 1dlmc02) 8cm x 12cm.Implant date: on (b)(6) 2007 [hospitalization dates unknown].Description of hernia being treated: ¿the patient had a surprisingly large incisional hernia in a supraumbilical position.She was also noted to have an umbilical hernia with properitoneal fat.¿ ¿a hernia sac was identified and dissected free at the level of the fascia.Just inferior to this there was an umbilical hernia noted as well.I elected to take the skin of the umbilicus off the hernia sac.There was a thin rim of fascia between the two hernias, so i elected to divide this making one single hernia defect.The hernia sac was then divided with cautery at the level of fascia and sent off the field as a specimen.Omentum was present.No evidence of bowel.¿ implant size and fixation: ¿intraperitoneal placement of dual mesh was then performed with the rough side facing the peritoneum.Multiple 0 ethibond stitches were used to tack the mesh to the undersurface of the fascia circumferentially.The air was irrigated with antibiotic containing solution and suctioned dry.Once the fascia had been placed in a retrofascial position, the fascia itself was then closed over the top of this with a running 0 prolene stitch.¿ no post-operative records were provided.Explant preoperative complaints: on (b)(6) 2008: ¿she has developed a recurrence with new bulging and pain in the area consistent with recurrence.¿ explant procedure: ¿removal of unincorporated previous mesh with repair of the recurrent incisional hernia with bard composite mesh system.¿ explant date: on (b)(6) 2008 [hospitalization dates unknown].¿incision was made using a previous transverse scar, carried down through subcutaneous tissue.The mesh was encountered which essentially had not incorporated.The side of the dual mesh which was supposed to incorporate in the entire lower half had broken free from the fascia with a recurrent hernia.The mesh was completely excised and the fascial edges circumferentially freshened up completely circumferentially with freeing up of any omental adhesions back in the abdominal cavity.Once the fascial edges were freed, circumferentially anteriorly and posteriorly a large bard composite mesh was soaked in antibiotic irrigation and positioned in correct orientation.The prolene portion of the mesh was then sewn to the edges of the fascia circumferentially with 2-0 ethibond to give a repair without tension.¿ records confirm a non-gore device was implanted during on (b)(6) 2008 procedure.Relevant medical information: on (b)(6) 2008: ¿i and d [incision and drainage] of infected hernia repair wound.¿ ¿presented to the emergency room early this morning with erythematous incision and surrounding cellulitis.She is brought to surgery now for incision and drainage of same.¿ ¿her incision was reopened down to a seroma cavity which was evacuated after sending fluid for culture.The mesh was exposed and only partially incorporated suggesting potential mesh involvement.Rather than leaving the packing directly on the mesh and risking contamination it was felt best to irrigate and closed over a 10 blake drain pending cultures in an effort to preserve the mesh if possible.A 10 blake drain was placed into the wound cavity, brought out through a stab incision below and to the left of the incision and sutured to the skin with nylon suture.The wound was loosely reapproximated with nylon mattress sutures and sterile dressing applied.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿cutting gore® dualmesh® biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.Use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the mesh.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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